Drug Tracking Law Faces Delay

Lobbyists Push For Less Strict Regulation

TALLAHASSEE — A Florida law that could be a national model for how to keep tainted and counterfeit drugs from reaching customers is at risk of being weakened by the state Legislature.

Under pressure from pharmacy owners and powerful retail lobbyists, legislators are considering bills that would delay indefinitely the implementation of a new system for tracking all medicines from manufacturer to consumer.

The so-called "drug pedigree" system that Florida adopted in 2003 requiring a certificate of authenticity, or pedigree, for all drugs stems from findings by state prosecutors and investigations by the South Florida Sun-Sentinel.

The reports documented the hazards of counterfeit, expired, relabeled and mishandled drugs that slip into the mainstream supply.

Under a pedigree system, a paper or electronic record is kept to show every step a drug takes before reaching a patient. The pedigree is already required for about 30 medications, but the new system would expand the tracking system to all pharmaceuticals sold in the state.

Proponents say the tracking system is necessary because drugs often take a circuitous path before reaching a consumer's medicine cabinet, moving through multiple wholesalers. Without the paper trail, officials say, the drug pipeline is vulnerable to counterfeits.

As recently as 2001, state and federal health investigators traced at least $100 million in suspect drugs to wholesale firms located mainly in South Florida. Unscrupulous firms focused on expensive drugs used by cancer and AIDS patients, but they also have been caught with adulterated cholesterol pills, asthma inhalers and other medicine, according to Sun-Sentinel reports.

Prosecutors and state health officials say it is difficult to detect counterfeit drugs because modern technology allows counterfeiters to create nearly identical packaging. But drugs often are diluted, leaving patients and physicians unaware that a medicine is providing little or no therapeutic value.

Top aides to Gov. Jeb Bush and Attorney General Charlie Crist are attempting to push the pedigree system into place without delays.

"What we discovered was that you cannot easily tell the difference between a counterfeit and the real McCoy at a glance," said James McDonough, director of Florida's Office of Drug Control. "You can get a placebo or a slightly diluted drug, but the implications, especially if it's a child being treated for leukemia or an AIDS patient, can be horrendous."

McDonough and Florida Health Department Secretary John Agwunobi insist the pedigree system is affordable and will save lives.

"There's just no valid excuse for not going forward with implementing the law," he said. "There doesn't seem to be any legitimate complications in the tracking system. The implementation date was adequate and generous. This just isn't an impossible task."

That's not how lobbyists for many of Florida's retail pharmacies see it.

"I feel comfortable in saying that the changes with the credentialing of wholesalers and retailers, we've already had an impact on curtailing counterfeits," said Michael Jackson, executive vice president of the Florida Pharmacy Association, which represents more than 4,000 pharmacists in the state. "But moving to a full-scale, every drug pedigree system would be little more than a substantial administrative burden on pharmacies."

Since 2003, wholesalers have complained the law would create tons of paperwork, waste money tracking shipments and drive up drug prices. With as many as 30,000 medications in stock, they say it would be logistically impossible to segregate boxes from different sellers so they can be identified for pedigrees.

To help pharmacies and wholesalers prepare for the change, the law requiring a pedigree was put in place starting in 1993 for only the drugs deemed most susceptible to counterfeit, about 30 medicines such as Gammagard and Gamimune given to leukemia sufferers; Zoladex and Lupron given to men with prostate cancer; and Epogen, Procrit and Zofran used for chemotherapy patients, along with about 10 drugs used by patients with HIV/AIDS.

The pedigree process would require drug wholesalers and retail pharmacists to use special electronic monitoring devices or other methods to keep precise tabs on the drugs in their stock.

The pedigree requirement for all drugs doesn't begin until July 2006.

But bills filed in the Legislature at the request of the Florida Retail Federation and backed by the state's retail pharmacy lobby seek to omit implementing the pedigree for any more than the short list of drugs.

Rep. Juan Zapata, R-Miami, and Sen. Durell Peaden, R-Crestview, have authored the bills, which are expected to come up for debate this legislative session. Rep. Rene Garcia, a Miami Republican and chairman of a key House health committee who supports the legislation, is expected to conduct hearings on the bills as early as this week.